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Purpose: To determine the direct costs of therapy over 5 years of a European monotherapy cohort begun on a prostaglandin (PTG) versus timolol in patients with primary open-angle glaucoma or ocular hypertension. Methods: A retrospective, multicenter, active-controlled, observational study. Data were abstracted for European patients treated as initial monotherapy in 1996 or afterward, with 5 years of available records. Results: This study included 271 patients (166 on a PTG and 105 on timolol at baseline). The average cost/month/patient over 5 years was $45.47±12.61 for PTG and $31.50±15.47 for timolol ( P<0.001, based on German prices). After 5 years, although there was no difference in number of glaucoma medicines prescribed between groups (1.0 PTGs and 1.1 timolol, P=0.41), the timolol group demonstrated a higher intraocular pressure (17.7±2.9 vs. 16.5±3.0 mm Hg, P<0.001), more medication changes ( P=0.01), greater incidence of glaucomatous progression ( P=0.04), and less patients persistent on original monotherapy ( P<0.001) than the PTG cohort. Conclusions: Patients originally on timolol monotherapy have a lower cost of care over 5 years than those started on a PTG. However, timolol patients during follow-up may demonstrate a higher intraocular pressure, more progression, more medication changes, and lower persistency of the original monotherapy. [ABSTRACT FROM AUTHOR]